FDA Drug Development Workshop: Part One

The FDA Drug Development Workshop for chronic fatigue syndrome (CFS) and myalgic encephalomyelitis (ME) took place last week on the 25th and 26th of April. It was well attended by patients, advocates, doctors, representatives of the CDC and even a few pharmaceutical reps.

The workshop was also broadcast live over the internet, enabling many more people to follow what happened without being there in person. This meeting was an opportunity for us to be heard, and continues to be an opportunity as comments can still be added to the docket until August 2nd 2013.

For those interested in a summary, this will be the first of several articles which attempt to summarize 85,000 words of talk over two days into only a few thousand words. At the bottom of each article is a link to the video recordings on the FDA site, as well as a transcript of the video discussed in the article. At the top of each transcript, we have added a list of who talks in that video along with timestamps of when they talked, and timestamps are given throughout this article as well for your reference. This will allow you to skip ahead to the part of a video which interests you the most, in case you don’t fancy catching up on two full days of talking from start to finish. We hope this will be a useful resource for readers!

Day one of the workshop was divided into the following four segments, the first two of which are covered in this first article. The third and fourth segments of day one will be covered by a subsequent article.

An Introduction from the FDA, with an overview of FDA’s Patient-Focused Drug Development Initiative and an overview of the discussion format for the rest of the workshop [video one] [transcript]

Discussion 1: Disease Symptoms and Daily Impacts That Matter Most to Patients, starting with a panel of patients and representatives (Dr John Kaiser, Joseph Landson, Denise Lopez-Majano, Kim McCleary, Charlotte von Salis), and then followed by a large-group discussion. [video two] [transcript]

As the FDA meeting started in the afternoon on the first day, Dr Peterson very intelligently arranged a meeting titled “Scientifically Redefining CFS/ME”, taking place before the FDA-workshop began. This meeting was well-attended, with Dr. Enlander, Dr. Nancy Klimas, and others participating. The content of that meeting is not specifically discussed in this article, but if was nice to see our ME/CFS researchers making the most of the opportunity.

Day one, part one: An overview of FDA’s Patient-Focused Drug Development Initiative [video one] [transcript]

It appears from the opening presentation that the FDA was genuinely engaged and they seemed to understand that the illness is very serious and debilitating. They said that they wanted to listen to the patients and careers present, and learn from the researchers and clinicians already involved in the disease.

"…Our goal is to move forward,” said Admiral Sandra Kweder, Deputy Director in the Office of Planning and Informatics at the FDA, in her opening presentation. A good start, because patients are keener than anyone to move forward, and we have waited a long time to be heard.

Next, Theresa Mullin, Director, Office of Planning and Informatics, FDA [timestamp:13:50] talked about ‘Patient-focused Drug Development’, describing it as “an opportunity for patients to talk, and frankly, for everyone else to listen.” She said that this was the first time this initiative was being put in progress to get direct input from patients to help in FDA decision making, and “an important adjunct to our benefit/risk framework.”

She then went on to explain that as part of this framework, they want to gain insight into the clinical perspective of patients and caregivers, with a strong emphasis on the patient’s willingness to accept risk in treatment. This seems to be the most significant of several factors that the FDA is considering alongside questions about the severity of illness, degree of unmet need, clinical trial data, risk and safety. This change alone could signal a real and significant opportunity.

Earlier this year Ampligen was rejected, despite the fact that patients explained their willingness to take risks with treatments to have a chance at recovery. The importance of this new framework is that it is not drug specific, where such evidence from patients and clinicians is treated with some caution as it is more open to influence by people with vested interests.

What this new framework will do, by not being drug-specific, is set an unbiased target for every drug application for ME and CFS, and if we tell the FDA that we have no good treatments currently, are seriously debilitated and are willing to accept risk in taking a drug where safety data might be sketchy, the chances of a drug like Ampligen getting approved would probably be greater than before.

Something else that the FDA (and us) are hoping will come out of this new initiative, is better end-point measures for drug trials.

After this introduction, the microphone was passed to Sara Eggers, PhD. Office of Planning and Informatics, FDA [timestamp: 24:30], who explained the format of the discussions that would take place next. This isn’t terribly exciting, so you may want to skip it. It runs to the end of the first video.

Day One, Part Two: Disease Symptoms and Daily Impacts That Matter Most to Patients [video two][transcript]

After a break, the workshop was reconvened with a panel of patients and representatives reporting on Disease Symptoms and Daily Impacts That Matter Most to Patients

What are the most significant symptoms that you experience resulting from your condition?

What are the most negative impacts on your daily life that result from your condition and its symptoms?

Dr. Jon Kaiser: A medical practicing Doctor in San Francisco who came down with CFS in 1987 [timestamp 00:57 – 05:40]

Dr. Jon Kaiser

Jon describes himself as being able to work during the week, with limitations, and then crashing each weekend at home. “I’m here to speak for the thousands of people with CFS who are able to work, but struggle to make it through each day and each week,” he said. He spends Saturdays and Sundays in bed in order to be able to return to work on Monday.

The greatest toll is on his family because he can’t attend to his children and to social events. He explains “I don’t know if I can convey the psychological distress I feel when I’m unable to spend time with my daughters, or participate in family activities.”

He struggles with the fact that family and friends can’t understand how he can feel so sick at home when he’s able to work and hold a job.

Joseph used to be a military linguist and now he can’t finish his thesis. This is his seventh year into a two year master’s program. He used to do translations in complicated languages like Arabic. At times, multiple translations at once while listening in on each ear. Today, he can be writing down something and when he reads it back the next day, he doesn’t comprehend it. He questions then whether he was confused when he wrote it or is it that he is totally confused while reading it back? “In a sense it doesn’t matter,” he says. “The previous day’s work is probably wasted.”

Denise's sons were 12 and 15 when they first got ill. They were athletic and very active academically and socially, with a full schedule. Today, they are both housebound. “Because they require 24/7 care,” Denise states, “I’m nearly as housebound as they are.” Their most problematic symptom is their impaired executive functioning and slow processing speed. Not only are they impaired cognitively, but when trying to concentrate for more than 20 minutes, they will collapse for weeks (PEM/PENE). Because of this, they cannot study without functional collapse.

The breakdown of age of onset of symptoms is as follows:18 years or younger - 25019 to 35 - 50036 to 50 - 45251 and older - 157

Average age of illness duration: 18 years!

Answering the question of what has had the most ‘impact on daily life’:

Fear of increased death or disease.

Life is not worth living or life stops – because of loss of career, social life etc.

Lack of effective treatments (unmet need).

Can’t work because of sleeplessness, medication side effect, muscle pain, migraines, blurred vision and exhaustion.

Social isolation.

Charlotte von Salis: Lawyer, ill for 22 years. She fits the ME-ICC and the CCC criteria [timestamp 19:53 – 23:57]

Charlotte von Salis

She used to work as a lawyer and is now unemployed and housebound. Her most troublesome symptom is her neurological and cognitive deficits. She cannot concentrate and has trouble understanding. Her IQ has been reduced to 107. She also has great sensitivity to light (was wearing sunglasses indoors) as well as to sound. “I can’t focus with much visual stimulation, for example: too many objects in a store, music in a restaurant or a busy website.”

Audience of patients and patient representatives add to the dialogue [Last 38 mins]

Sara (moderator) asked about the following issues:

Cognitive symptoms

Patients replied with the following difficulties:

Short term memory loss was mentioned by a few, along with loss of concentration and/or focus. Many expressed problems with word-finding. One expressed that it was so bad as to cause them to stutter.

The cognitive issues cause patients to have difficulties with decision-making.

Multi-tasking problems, especially for those who are still working. They can only concentrate on one thing at a time.

Speaking difficulty was mentioned, especially in the context of the effort that it takes to testify at this meeting which comes at a great cost to the patient participants (big thanks to our heroes who attended and participated for us!!!). Many mentioned how they will suffer for this later, for days or weeks.

Sara suggested that this mental confusion must be causing anxiety? I loved Joan’s reply: No, it does not cause anxiety. It causes fear. The difference between anxiety and fear is that anxiety is a worry about something that might happen. Whereas fear is worry about something one knows will happen.

Crashes

The following were mentioned regarding crashes:

They are unpredictable – one day an activity can be okay and on another day it can cause a crash. At times, a crash will happen with no apparent reason.

Most agreed that when one is crashing, whether because of physical or mental effort, it shows up as a worsening of all symptoms (not just fatigue).

One person described a crash as something that she can feel instantly: “a change in my whole body”.

Many feel that the lack of quality sleep, or unrefreshing sleep, is a trigger for their crash or worsening of symptoms.

The length of a crash could be a day, a week or months (years?). Someone described it as “a moving target” – no one knows what the price will be for any given activity whether mental or physical.

Some know what their envelope of activity can hold; others don’t because it changes all the time.

Important Issues

A person mentioned that their crash correlates with the findings of low NK-cells and high viral titers. We do have Science to measure this (most important to note!).

Measurable symptoms when crashing that were mentioned: a sore throat, fever/chills and a worsening of GI problems like IBS.

Just like diabetes that has the main identifiable symptom of high blood sugar and then many variable symptoms, so too CFS must have, besides all these variable symptoms, a main common symptom – it just has not been identified yet.

A sentiment heard from a few patients: “it’s nice to have a place to be heard.”

Day 1, Part 2: Discussion: Disease Symptoms and Daily Impacts That Matter Most to PatientsVideoTranscript

Coming soon: In the next article in this series, we'll review the third video, covering the third and fourth sessions from day one of the workshop.

Joel was diagnosed with ME/CFS in 2009 but struggled with the illness for some time prior to this. He loves to write, and hopes to regain enough health to return to the career he loved and have his work published.​

Gabby is a patient with ME/CFS - disabled since 2003. She is passionate about raising awareness of the plight of severe sufferers of this disease.​

Phoenix Rising is a registered 501 c.(3) non profit. We support ME/CFS and NEID patients through rigorous reporting, reliable information, effective advocacy and the provision of online services which empower patients and help them to cope with their isolation.

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There is going to be a parts 2 and 3? I can hardly wait. To be told by an FDA doctor to take anti-depressants, Lyrica, Cymbalta, anti-convulsives, anti-seizures meds. More horse dung. Stuff they were conned, forced into approving by greedy companies, supposedly for "pain." I really hope you didn't put that much time into all this, because medicine by government committee is a waste of time.

All of this could have been put out by the Chronic Fatigue Association of America back in 1997. Do you really think any of this info adds anything valuable to the discussion? The fact that people get PEM? They get cognitive issues? There is absolutely no room for common sense in any of this. Not one new photon of light was shed on CFS. And anything that includes Kim McClearly is automatically going to be doctrinaire baloney.

Like the quote from Dr. Kaiser. Before he said that he
acknowledged housebound & bedridden patients who
are more disabled than he & unable to attend such
meetings. Be nice if speakers at future public meetings
did the same.

There is going to be a parts 2 and 3? I can hardly wait. To be told by an FDA doctor to take anti-depressants, Lyrica, Cymbalta, anti-convulsives, anti-seizures meds. More horse dung. Stuff they were conned, forced into approving by greedy companies, supposedly for "pain." I really hope you didn't put that much time into all this, because medicine by government committee is a waste of time.

Click to expand...

I am afraid I am going to have to agree with your cynicism.

I would not at all be surprised if Lyrica and Cymbalta are the two drugs pushed through for possible approval.

Seriously though, What drugs ARE they considering? What is out there that we are hoping to get approved? Not including Ampligen. How many years have we been waiting for Ampligen approval!?! Is it REALLY going to happen ever? Cynicism again.

. So many drugs, are already used off label by patients, in fact it seems like most medications end up being used for a lot of conditions different from the original condition it was approved to treat.

What difference will approval make? (not including Ampligen)I know people outside the US have trouble getting certain meds prescribed as they are off label but will FDA approval affect their ability to have them prescribed and covered through NHS for example? I really do not know.

All of this could have been put out by the Chronic Fatigue Association of America back in 1997. Do you really think any of this info adds anything valuable to the discussion? The fact that people get PEM? They get cognitive issues? There is absolutely no room for common sense in any of this. Not one new photon of light was shed on CFS. And anything that includes Kim McClearly is automatically going to be doctrinaire baloney.

I would not at all be surprised of Lyrica and Cymbalta are the two drugs pushed through for possible approval.

Seriously though, What drugs ARE they considering? What is out there that we are hoping to get approved?

Sorry for being such a downer.

Click to expand...

I expect most of us understand the cynicism, and any pessimism!
There was nothing new, for us, in the conference, and it was a little bit regretful to see them asking the most basic of questions, such as "what symptoms do you get?"
And of course, there have been false starts in the past, and government agencies usually just mess up our lives.

However, watching the videos, I was very encouraged.
It's feels like a 'reset' button has been pressed by the FDA, and although they are asking the most basic of questions, this seemed to be a constructive process, as if they are actually hearing patients for the first time, starting with the fundamental nature of the illness. They appear to have an open mind, they appear to be sincere, and they appear to be listening carefully. And I mean actually 'listening' to patients, and hearing what we've got to say.
I really was encouraged, and I actually found it all quite heart warming. (Not something I'd often say about government agencies in action!)

Whether much comes of it, remains to be seen, of course.

The public were given an open mike, and many issues were touched upon, including: diagnostic criteria, biomarkers, research endpoints (how to measure improvements), and a variety of drug types were mentioned.

The FDA officials seemed to be saying that there are funds available, and that the researchers should approach them for help with designing and implementing clinical trials. Ampligen was mentioned a lot. Rituximab was mentioned. Immune modulators were mentioned. And more.

They discussed a range of biomarkers including VO2, genes, NK function, etc.

One biotech man even said that he wanted saliva from ME patients, so that he could test his medical saliva test, that he hopes can be developed into a quick biomarker test for fatigue! He said it wasn't yet specifically a CFS test, but it sounded interesting, and he's ready to do a trial with CFS patients.

I found it a very refreshing conference, in that, all the way through it, ME symptoms were being discussed in 'medical' (biomedical) terms, and never in psychiatric terms. This is a novel experience, for me, a UK patient, in terms of health authorities!

The patients present, were excellent advocates, and gave a very good account of the difficulties that we face. And these difficulties were always being interpreted in terms of biomedical problems that urgently need treatments.

The videos are well worth watching, for encouragement, IMO. I was very heartened, and encouraged by it all.

A number of our well known clinicians were there, and spoke, including Dan Paterson, and Nancy Klimas. Even Judy Mikovits spoke.

I expect most of us understand the cynicism, and any pessimism!
There was nothing new, for us, in the conference, and it was a little bit regretful to see them asking the most basic of questions, such as "what symptoms do you get?"
And of course, there have been false starts in the past, and government agencies usually just mess up our lives.

However, watching the videos, I was very encouraged.
It's feels like a 'reset' button has been pressed by the FDA, and although they are asking the most basic of questions, they appear to be sincere, and they appear to be listening carefully. And I mean actually 'listening' to patients, and hearing what we've got to say.
I really was encouraged, and I actually found it all quite heart warming. (Not something I'd often say about government agencies in action!)

Whether much comes of it, remains to be seen, of course.

.

Click to expand...

I agree with you Bob. I watched the webcasts live and now again and I was struck with the same feeling. I know that this is government and all...but, there seemed to be a genuine eagerness to find out as much as they can. The whole setting and the way they conduced themselves were very respectful. After giving my own testimony and watching many CFSAC workshops, this in comparison, was very refreshing to see.

I understand and share everyone's frustrations and I have no idea if anything will eventually come out of this. I do know that at least, they will be better informed in the future.

All of this could have been put out by the Chronic Fatigue Association of America back in 1997. Do you really think any of this info adds anything valuable to the discussion? The fact that people get PEM? They get cognitive issues? There is absolutely no room for common sense in any of this. Not one new photon of light was shed on CFS. And anything that includes Kim McClearly is automatically going to be doctrinaire baloney.

I would not at all be surprised of Lyrica and Cymbalta are the two drugs pushed through for possible approval.

Seriously though, What drugs ARE they considering? What is out there that we are hoping to get approved?

Sorry for being such a downer.

Click to expand...

I expect most of us understand the cynicism, and any pessimism!
There was nothing new, for us, in the conference, and it was a little bit regretful to see them asking the most basic of questions, such as "what symptoms do you get?"
And of course, there have been false starts in the past, and government agencies usually just mess up our lives.

However, watching the videos, I was very encouraged.
It's feels like a 'reset' button has been pressed by the FDA, and although they are asking the most basic of questions, this seemed to be a constructive process, as if they are actually hearing patients for the first time, starting with the fundamental nature of the illness. They appear to have an open mind, they appear to be sincere, and they appear to be listening carefully. And I mean actually 'listening' to patients, and hearing what we've got to say.
I really was encouraged, and I actually found it all quite heart warming. (Not something I'd often say about government agencies in action!)

Whether much comes of it, remains to be seen, of course.

The public were given an open mike, and many issues were touched upon, including: diagnostic criteria, biomarkers, research endpoints (how to measure improvements), and a variety of drug types were mentioned.

The FDA members seemed to be saying that there are funds available, and that the researchers should approach them for help with designing and implementing clinical trials. Ampligen was mentioned a lot. Rituximab was mentioned. Immune modulators were mentioned. And more.

They discussed a range of biomarkers including VO2, genes, NK function, etc.

One biotech man even said that he wanted saliva from ME patients, so that he could test his medical saliva test, that he hopes can be developed into a quick biomarker test for fatigue! He said it wasn't yet specifically a CFS test, but it sounded interesting, and he's ready to do a trial with CFS patients.

I found it a very refreshing conference, in that, all the way through it, ME symptoms were being discussed in 'medical' (biomedical) terms, and never in psychiatric terms. This is a novel experience, for me, a UK patient, in terms of health authorities!

The patients present, were excellent advocates, and gave a very good account of the difficulties that we face. And these difficulties were always being interpreted in terms of biomedical problems that urgently need treatments.

The videos are well worth watching, for encouragement, IMO. I was very heartened, and encouraged by it all.

A number of our well known clinicians were there, and spoke, including Dan Paterson, and Nancy Klimas. Even Judy Mikovits spoke.

Click to expand...

Right on Bob! Excellent and accurate post. I lost faith many years ago in Gov sincerity in anything having to do with this disease......yet this conference appears to open a new chapter with lots in our favor.

Huge thanks to all those physicians involved, especially to Dr Peterson who gave of his time to fight yet another fight for us.....this in spite of lacking an invitation to participate. Thanks to all the PwME who gave of their precious and limited time who likely paid a price later. Thanks to the authors of this article who gave much of themselves as well.

Right on Bob! Excellent and accurate post. I lost faith many years ago in Gov sincerity in anything having to do with this disease......yet this conference appears to open a new chapter with lots in our favor.

Huge thanks to all those physicians involved, especially to Dr Peterson who gave of his time to fight yet another fight for us.....this in spite of lacking an invitation to participate. Thanks to all the PwME who gave of their precious and limited time who likely paid a price later. Thanks to the authors of this article who gave much of themselves as well.

T

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A brand new immune modulating drug was just approved for MS. It's called BG-12. It is being prescribed now to patients (literally starting this month). The stock of the company of Biogen shot through the roof because the trial results were so convincing. It really WORKS, in other words, unlike the crap that we hoping to get to take. Plus, it is entirely free of serious side effects. Lucky for you MS patients!!

Not one of our devoted, paleolithic doctors has mentioned this as a possible dual-use medication for CFS. They should NOT be invited to speak simply because they "believe" in CFS; because they have no new ideas;. They are utter intellectual wastelands of new ideas. He and she are stuck back in the 90s, or 80s. If they treated you kindly, fine!! Invite them to your next backyard BBQ. But don't kept pushing them up as heroes of our illness. They are proven failures.

Giving CFS patients antibiotics, anti-virals is a proven failure. There is nothing there. Start over. Reboot the machine. Jettison the dead weight doctors (Klimas, Peterson, et al) and start over with new imaginative treatment modalities. And DON'T expect the federal government, at a time when it is ACTUALLY SHRINKING, to put together an effective treatment for this illness.

MishMash - I can't see that what you're proposing makes any logical sense. We all want to see flesh blood in the field, bringing new ideas and approaches with them, but the way to achieve that isn't to "jettison" the few people who are already working in the field. Quite the opposite in fact. We need our experienced doctors to help get young researchers interested and to support them in taking their first steps in the ME/CFS arena which is so full of stigma and ridicule. Enlander, for instance, has a fellowship programme at Mt. Sinai which is introducting new young researchers to the field.

I'd be intererested to hear how you would go about rebooting the machine and getting fresh blood involved in ME/CFS having removed all our current doctors.

A brand new immune modulating drug was just approved for MS. It's called BG-12. It is being prescribed now to patients (literally starting this month). The stock of the company of Biogen shot through the roof because the trial results were so convincing. It really WORKS, in other words, unlike the crap that we hoping to get to take. Plus, it is entirely free of serious side effects. Lucky for you MS patients!!

Click to expand...

Not so as far as side effects....I was just on an MS forum while researching BG-12. Interesting because some MS patients realized that make huge money for drug companies and the not all MS patients trust the drugs being approved. From one site, I learned that the one year cost for one patient to be treated with BG-12 is $54,000.

Turns out BG-12 (dimethyl fumarate) has been in other treatments like Fumaderm for psoriasis and Panoplin. The forums are talking about the fumarates and PML.

WEDNESDAY, April 24 (HealthDay News) -- The active ingredient in a drug that's expected to become a popular treatment for multiple sclerosis has been linked to four European cases of a rare but sometimes fatal brain disease called progressive multifocal leukoencephalopathy (PML).The ingredient, dimethyl fumarate, is used in a drug called Fumaderm that was approved in Germany in 1994 to treat the skin condition psoriasis. It is also in a different but closely related medication called Tecfidera, which was just approved by the U.S. Food and Drug Administration in March for the treatment of multiple sclerosis (MS). It is known as a fumaric acid ester, which is commonly used as a food additive and has been used to treat psoriasis in Germany for 30 years.According to reports published in the April 25 issue of the New England Journal of Medicine, however, four patients who were taking Fumaderm to treat their psoriasis developed PML.

Right on Bob! Excellent and accurate post. I lost faith many years ago in Gov sincerity in anything having to do with this disease......yet this conference appears to open a new chapter with lots in our favor.

Huge thanks to all those physicians involved, especially to Dr Peterson who gave of his time to fight yet another fight for us.....this in spite of lacking an invitation to participate. Thanks to all the PwME who gave of their precious and limited time who likely paid a price later. Thanks to the authors of this article who gave much of themselves as well.

T

Click to expand...

A brand new immune modulating drug was just approved for MS. It's called BG-12. It is being prescribed now to patients (literally starting this month). The stock of the company of Biogen shot through the roof because the trial results were so convincing. It really WORKS, in other words, unlike the crap that we hoping to get to take. Plus, it is entirely free of serious side effects. Lucky for you MS patients!!

Not one of our devoted, paleolithic doctors has mentioned this as a possible dual-use medication for CFS. They should NOT be invited to speak simply because they "believe" in CFS; because they have no new ideas;. They are utter intellectual wastelands of new ideas. He and she are stuck back in the 90s, or 80s. If they treated you kindly, fine!! Invite them to your next backyard BBQ. But don't kept pushing them up as heroes of our illness. They are proven failures.

Giving CFS patients antibiotics, anti-virals is a proven failure. There is nothing there. Start over. Reboot the machine. Jettison the dead weight doctors (Klimas, Peterson, et al) and start over with new imaginative treatment modalities. And DON'T expect the federal government, at a time when it is ACTUALLY SHRINKING, to put together an effective treatment for this illness.

"A brand new immune modulating drug was just approved for MS. It’s called BG-12. It is being prescribed now to patients (literally starting this month). The stock of the company of Biogen shot through the roof because the trial results were so convincing. It really WORKS, in other words, unlike the crap that we hoping to get to take. Plus, it is entirely free of serious side effects. Lucky for you MS patients!!

Not one of our devoted, paleolithic doctors has mentioned this as a possible dual-use medication for CFS."

Multiple sclerosis has several intriguing associations with ME/CFS including an infectious mononucleosis trigger, a relapsing/remitting nature, possible herpesvirus activation and high rates of fatigue (that are not associated with demyelination). The neuroprotective effects of a novel oral treatment, BG12 (dimethyl fumarate) has been recently shown to slow disease progression in relapsing/remitting MS in phase III trials. Neural degeneration in MS is believed to be mediated by oxidative stress and an analysis of the neuroprotective effects of dimethyl fumarate suggests that these effects are due to enhancing the recycling of glutathione, a key antioxidant. (Lee et al, 2012).

This is intriguing because the experimental model used to simulate neurodegeneration in MS involves both glutamate toxicity and glutathione depletion. It suggests that extracellular glutamate leads to deprivation of cystine and its reduced form cysteine, which is the rate-limiting substrate for the synthesis of glutathione. The subsequent glutathione depletion gives rise to the accumulation of reactive oxygen species and cell death by oxidative stress (Albrecht et al, 2012).

The one lady mentions we feel fear not anxiety I understand what shes saying I agree that it's not anxiety. But I worry and feel that the FDA (Government) won't understand the context shes talking about. Or equates 'Fear' of a crash to being the act of Fear Avoidance. And/Or think our symptoms (the crash) are psychosomatic and brought on by our fear. That if we addressed our fear via therapy we wont crash.

The one lady mentions we feel fear not anxiety I understand what shes saying I agree that it's not anxiety. But I worry and feel that the FDA (Government) won't understand the context shes talking about. Or equates 'Fear' of a crash to being the act of Fear Avoidance. And/Or think our symptoms (the crash) are psychosomatic and brought on by our fear. That if we addressed our fear via therapy we wont crash.

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I think that this was a response to the moderator's previous comment saying "you probably feel anxiety regarding crashing". I think (imo) that she was trying to banish the word "anxiety" as it has psychiatric connotations. What we feel is really "fear" of what we know is going to follow.